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Splinting After Mini-Open Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No Splint
Removable Splint
Non-removable Splint
Sponsored by
Anthony L. Logli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring postoperative dressing, postoperative splint, mini-open carpal tunnel release

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS.

Exclusion Criteria:

  • Exclusion criteria omitted patients who presented with acute onset CTS, concomitant peripheral neuropathy, metabolic disease, postoperative recurring CTS, or who required another operative procedure during carpal tunnel release.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    No splint

    Removable Splint

    Non-removable Splint

    Arm Description

    Outcomes

    Primary Outcome Measures

    QuickDASH
    The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
    Levine-Katz Symptom Severity Scale (SSS)
    The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
    Numerical Pain Rating Scale
    Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
    Grip Strength
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
    Wrist Flexion
    Lateral Pinch Strength
    Lateral pinch strength was taken with a Preston Pinch Gauge.

    Secondary Outcome Measures

    Demographic Information
    Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status
    Complications
    Complications were observed for and recorded throughout the study.

    Full Information

    First Posted
    August 22, 2016
    Last Updated
    August 25, 2016
    Sponsor
    Anthony L. Logli
    Collaborators
    University of Illinois at Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02885701
    Brief Title
    Splinting After Mini-Open Carpal Tunnel Release
    Official Title
    A Prospective, Randomized Controlled Study of Splinting After Mini-Open Carpal Tunnel Release
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Anthony L. Logli
    Collaborators
    University of Illinois at Chicago

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if any difference exists among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery.
    Detailed Description
    We sought to determine if any significant difference in patient-reported or clinical outcomes existed among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery for symptomatic, isolated, nerve conduction study positive carpal tunnel syndrome (CTS). A total of 249 patients received a mini-open CTR and were subsequently randomized into 1 of the 3 splinting regimens to be removed at the first postoperative visit 10-14 days later. Patient-reported outcomes included QuickDASH surveys, Levine-Katz Symptom Severity Scale (SSS) and Functional Status Scale (FSS) and Pain at Rest and in Action using a Numerical Pain Rating Scale (NPRS). Clinical outcomes included wrist range of motion (ROM), grip and lateral pinch strengths. All outcomes were evaluated bilaterally at 10-14 days, 6 weeks, 3 months, 6 months and 12 months after surgery. Demographic information was obtained preoperatively and complications were observed for and recorded throughout the study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome
    Keywords
    postoperative dressing, postoperative splint, mini-open carpal tunnel release

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    249 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No splint
    Arm Type
    Experimental
    Arm Title
    Removable Splint
    Arm Type
    Experimental
    Arm Title
    Non-removable Splint
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    No Splint
    Intervention Description
    The no splint group received a soft dressing consisting of an occlusive petroleum gauze strip (Xeroform, Mansfield, MA) over the wound, one folded 4x4 gauze, and a single wrap of roll gauze around the hand, and the wrist was placed and secured by a Coban wrap (3M, St. Paul, MN). The dressing permitted wrist and finger motion. Patients were further instructed to remove the dressing at five days and place an adhesive bandage (Band-Aid, Johnson & Johnson, New Brunswick, NJ) over the incision.
    Intervention Type
    Other
    Intervention Name(s)
    Removable Splint
    Intervention Description
    The removable splint group received a V-strap Wrist support (Medical Specialties, Inc., Charlotte, NC) placed over the identical soft dressing that was placed on the no splint group. The cock-up wrist splint was designed to keep the wrist fixed in a 20 degree extended wrist position. Patients were instructed to wear the splint for comfort as needed during day and night. While the patient was wearing the cock-up splint, only finger motion was permitted. Wrist motion was permitted when the cock-up splint was removed.
    Intervention Type
    Other
    Intervention Name(s)
    Non-removable Splint
    Intervention Description
    The plaster non-removable splint group received an occlusive petroleum gauze strip placed over the wound, followed by a 4X4 gauze, and a Webril cotton roll wrap (Covidien, Inc., Covidien, Ireland). A 4- inch, 15-layer thick plaster splint was placed across the volar wrist and molded to keep the wrist in approximately 20 degrees of extension allowing full digital range of motion (ROM). The splint was to be kept dry and not removed by the patient.
    Primary Outcome Measure Information:
    Title
    QuickDASH
    Description
    The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
    Time Frame
    10-14 days postoperatively
    Title
    Levine-Katz Symptom Severity Scale (SSS)
    Description
    The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
    Time Frame
    10-14 days postoperatively
    Title
    Numerical Pain Rating Scale
    Description
    Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
    Time Frame
    10-14 days postoperatively
    Title
    Grip Strength
    Description
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
    Time Frame
    10-14 days postoperatively
    Title
    Wrist Flexion
    Time Frame
    10-14 days postoperatively
    Title
    Lateral Pinch Strength
    Description
    Lateral pinch strength was taken with a Preston Pinch Gauge.
    Time Frame
    10-14 days postoperatively
    Secondary Outcome Measure Information:
    Title
    Demographic Information
    Description
    Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status
    Time Frame
    Preoperatively
    Title
    Complications
    Description
    Complications were observed for and recorded throughout the study.
    Time Frame
    10-14 days postoperatively
    Other Pre-specified Outcome Measures:
    Title
    QuickDASH
    Description
    The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
    Time Frame
    6 weeks postoperatively
    Title
    QuickDASH
    Description
    The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
    Time Frame
    3 months postoperatively
    Title
    QuickDASH
    Description
    The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
    Time Frame
    6 months postoperatively
    Title
    QuickDASH
    Description
    The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time
    Time Frame
    12 months postoperatively
    Title
    Levine-Katz Functional Status Scale (FSS)
    Description
    The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
    Time Frame
    10-14 days postoperatively
    Title
    Levine-Katz Functional Status Scale (FSS)
    Description
    The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
    Time Frame
    6 weeks postoperatively
    Title
    Levine-Katz Functional Status Scale (FSS)
    Description
    The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
    Time Frame
    3 months postoperatively
    Title
    Levine-Katz Functional Status Scale (FSS)
    Description
    The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
    Time Frame
    6 months postoperatively
    Title
    Levine-Katz Functional Status Scale (FSS)
    Description
    The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function.
    Time Frame
    12 months postoperatively
    Title
    Levine-Katz Symptom Severity Scale (SSS)
    Description
    The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
    Time Frame
    6 weeks postoperatively
    Title
    Levine-Katz Symptom Severity Scale (SSS)
    Description
    The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
    Time Frame
    3 months postoperatively
    Title
    Levine-Katz Symptom Severity Scale (SSS)
    Description
    The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
    Time Frame
    6 months postoperatively
    Title
    Levine-Katz Symptom Severity Scale (SSS)
    Description
    The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported.
    Time Frame
    12 months postoperatively
    Title
    Numerical Pain Rating Scale
    Description
    Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
    Time Frame
    6 weeks postoperatively
    Title
    Numerical Pain Rating Scale
    Description
    Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
    Time Frame
    3 months postoperatively
    Title
    Numerical Pain Rating Scale
    Description
    Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
    Time Frame
    6 months postoperatively
    Title
    Numerical Pain Rating Scale
    Description
    Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity.
    Time Frame
    12 months postoperatively
    Title
    Grip Strength
    Description
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
    Time Frame
    6 weeks postoperatively
    Title
    Grip Strength
    Description
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
    Time Frame
    3 months postoperatively
    Title
    Grip Strength
    Description
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
    Time Frame
    6 months postoperatively
    Title
    Grip Strength
    Description
    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.
    Time Frame
    12 months postoperatively
    Title
    Wrist Flexion
    Time Frame
    6 weeks postoperatively
    Title
    Wrist Flexion
    Time Frame
    3 months postoperatively
    Title
    Wrist Flexion
    Time Frame
    6 months postoperatively
    Title
    Wrist Flexion
    Time Frame
    12 months postoperatively
    Title
    Wrist Extension
    Time Frame
    10-14 days postoperatively
    Title
    Wrist Extension
    Time Frame
    6 weeks postoperatively
    Title
    Wrist Extension
    Time Frame
    3 months postoperatively
    Title
    Wrist Extension
    Time Frame
    6 months postoperatively
    Title
    Wrist Extension
    Time Frame
    12 months postoperatively
    Title
    Lateral Pinch Strength
    Description
    Lateral pinch strength was taken with a Preston Pinch Gauge.
    Time Frame
    6 weeks postoperatively
    Title
    Lateral Pinch Strength
    Description
    Lateral pinch strength was taken with a Preston Pinch Gauge.
    Time Frame
    3 months postoperatively
    Title
    Lateral Pinch Strength
    Description
    Lateral pinch strength was taken with a Preston Pinch Gauge.
    Time Frame
    6 months postoperatively
    Title
    Lateral Pinch Strength
    Description
    Lateral pinch strength was taken with a Preston Pinch Gauge.
    Time Frame
    12 months postoperatively
    Title
    Complications
    Description
    Complications were observed for and recorded throughout the study.
    Time Frame
    6 weeks postoperatively
    Title
    Complications
    Description
    Complications were observed for and recorded throughout the study.
    Time Frame
    3 months postoperatively
    Title
    Complications
    Description
    Complications were observed for and recorded throughout the study.
    Time Frame
    6 months postoperatively
    Title
    Complications
    Description
    Complications were observed for and recorded throughout the study.
    Time Frame
    12 months postoperatively

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS. Exclusion Criteria: Exclusion criteria omitted patients who presented with acute onset CTS, concomitant peripheral neuropathy, metabolic disease, postoperative recurring CTS, or who required another operative procedure during carpal tunnel release.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian J Bear, MD
    Organizational Affiliation
    OrthoIllinois
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    12371039
    Citation
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    Splinting After Mini-Open Carpal Tunnel Release

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